STELARA 45 MG VIAL

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

USTEKINUMAB

Beschikbaar vanaf:

J-C HEALTH CARE LTD

ATC-code:

L04AC05

farmaceutische vorm:

SOLUTION FOR INJECTION

Samenstelling:

USTEKINUMAB 45 MG / 0.5 ML

Toedieningsweg:

S.C

Prescription-type:

Required

Geproduceerd door:

CILAG AG, SWITZERLAND

Therapeutische categorie:

USTEKINUMAB

Therapeutisch gebied:

USTEKINUMAB

therapeutische indicaties:

*Plaque psoriasisSTELARA is indicated for the treatment of moderate to severe plaque psoriasis in adult patients (18 years or older) who have failed to, have a contraindication to, or who are intolerant to other systemic therapies including ciclosporin, methotrexate or Psoralen plus U.V (PUVA) Paediatric plaque psoriasisSTELARA is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, othersystemic therapies or phototherapies.Psoriatic arthritis (PsA)STELARA, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease modifying anti rheumatic drug (DMARD) therapy has been inadequateCrohn’s DiseaseSTELARA is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.Ulcerative colitisSTELARA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies

Autorisatie datum:

2014-12-31

Bijsluiter

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
STELARA
®
45 mg Vial, Solution for Injection
STELARA
®
Pre-filled Syringe, 45 mg, Solution
for Injection
STELARA
®
Pre-filled Syringe, 90 mg, Solution
for Injection
Active ingredient and its quantity:
Each vial contains:
ustekinumab 45 mg/0.5 ml
Each 0.5 ml pre-filled syringe contains:
ustekinumab 45 mg
Each 1 ml pre-filled syringe contains:
ustekinumab 90 mg
Inactive and allergenic ingredients in the preparation – see section
6 “Further
Information”.
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions, refer
to the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them even if it seems to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Plaque psoriasis
Stelara is indicated for the treatment of moderate to severe plaque
psoriasis in adult
patients (18 years or older) who have failed to, have a
contraindication to, or who are
intolerant to other systemic therapies including ciclosporin,
methotrexate or Psoralen
plus U.V (PUVA).
Plaque psoriasis in children
Stelara is indicated for the treatment of moderate to severe plaque
psoriasis in children
and adolescent patients from the age of 6 years and older, who are
inadequately
controlled by, or are intolerant to, other systemic therapies or
phototherapies.
Psoriatic arthritis
(
PsA)
Stelara, alone or in combination with methotrexate, is indicated for
the treatment of
active psoriatic arthritis in adult patients, when the response to
previous non-biological
disease modifying anti rheumatic drug (DMARD) therapy has been
inadequate.
Crohn’s disease
Stelara is indicated for the treatment of adult patients with
moderately to severely
active Crohn’s disease who have had an inadequate response with,
lost resp

Productkenmerken

Stelata PFS_PVP_SPC_07_2023
1.
NAME OF THE MEDICINAL PRODUCT
STELARA 45 mg Vial
STELARA pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-use vial contains 45 mg ustekinumab in 0.5 mL
Each single-use 45 mg pre-filled syringe contains 45 mg ustekinumab in
0.5 mL
Each single-use 90 mg pre-filled syringe contains 90 mg ustekinumab in
1.0 mL
Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin
(IL)-12/23 produced in a
murine myeloma cell line using recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in vial.
Solution for injection in pre-filled syringe (injection).
The solution is clear to slightly opalescent, colourless to light
yellow.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Plaque psoriasis
STELARA is indicated for the treatment of moderate to severe plaque
psoriasis in adult patients (18 years or
older) who have failed to, have a contraindication to, or who are
intolerant to other systemic therapies including
ciclosporin, methotrexate or Psoralen plus U.V (PUVA) (see section
5.1).
Paediatric plaque psoriasis
STELARA is indicated for the treatment of moderate to severe plaque
psoriasis in children and
adolescent patients from the age of 6 years and older, who are
inadequately controlled by, or are
intolerant to, other systemic therapies or phototherapies (see section
5.1).
Psoriatic arthritis (PsA)
STELARA, alone or in combination with MTX, is indicated for the
treatment of active psoriatic
arthritis in adult patients when the response to previous
non-biological disease-modifying
anti-rheumatic drug (DMARD) therapy has been inadequate (see section
5.1).
Crohn’s Disease
STELARA is indicated for the treatment of adult patients with
moderately to severely active Crohn’s
disease who have had an inadequate response with, lost response to, or
were intolerant to either
conventional therapy or a TNFα antagonist or have medical
contraindications to such therapies.
Ulcerative colitis
STELARA is